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510(k) K200754

Hemosure Accu-Reader A100 by W.H.P.M., Inc. — Product Code OOX

K200754 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "Hemosure Accu-Reader A100". The FDA issued a decision of Substantially Equivalent on June 2, 2022. The device falls under product code OOX (Automated Occult Blood Analyzer), a Class II device regulated under 21 CFR 864.6550. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2022
Date Received
March 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Occult Blood Analyzer
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

Other clearances by W.H.P.M., Inc.

  • K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign (August 12, 2021)
  • K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign (February 5, 2018)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152551 — First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Bupr (November 9, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (October 7, 2014)
  • K052197 — FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (June 9, 2006)
  • K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (August 22, 2005)
  • K041202 — HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST (August 12, 2004)

Other clearances for product code OOX

  • K191147 — OC-Auto SENSOR io iFOB Test (January 2, 2020)
  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K132167 — I-CHROMA IFOB WITH I-CHROMA READER (May 2, 2014)
  • K092330 — OC-SENSOR DIANA IFOB TEST (January 8, 2010)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)

FDA data resources